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510(k) K922441

SURESEAL BANDAGE by Gainor Medical Europe, Ltd. — Product Code KGX

K922441 is an FDA 510(k) premarket notification submitted by Gainor Medical Europe, Ltd. for the device "SURESEAL BANDAGE". The FDA issued a decision of Substantially Equivalent on August 10, 1993. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Gainor Medical Europe, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1993
Date Received
May 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Gainor Medical Europe, Ltd.

  • K926448 — I.V. ADMINISTRATION SET (May 2, 1994)
  • K931828 — CARELET SAFETY LANCET (October 15, 1993)
  • K931827 — CLEANLET, CLEANLET XL & KIDS (September 13, 1993)
  • K913333 — I.V. PRIMING SET (October 23, 1991)
  • K902422 — NEEDLE, ASPIRATION & INJECTION, DISPOSABLE (June 6, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K902564 — NEEDLE, DIALYSIS (March 1, 1991)
  • K902426 — HEMODIALYSIS SYSTEM AND ACCESSORY (November 20, 1990)
  • K902421 — STOMACH, GASTRO-ENTEROSTOMY (November 20, 1990)
  • K902416 — SURELITE AND SURELITE XL BLOOD LANCET (August 1, 1990)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources